# China NMPA Drug Inspection - Shanxi Kangyi Hengtai Pharmaceutical Co., Ltd. - Fried Fructus Aurantii Immaturus

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanxi-kangyi-hengtai-pharmaceutical-co-ltd/cbba2510-6309-4768-bc75-7690fd6f776b/
Source feed: China

> China NMPA drug inspection for Shanxi Kangyi Hengtai Pharmaceutical Co., Ltd. published November 28, 2017. Drug: Fried Fructus Aurantii Immaturus. On November 28, 2017, the Shaanxi Provincial Food and Drug Administration published an announcement detailing findings f

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shaanxi Province Drug Quality Bulletin
- Company Name: Shanxi Kangyi Hengtai Pharmaceutical Co., Ltd.
- Publication Date: 2017-11-28
- Drug Name: Fried Fructus Aurantii Immaturus
- Inspection Finding: [Characteristics]
- Action Taken: The relevant municipal (county, district) food and drug administration departments have taken necessary control measures and are investigating and handling the matter in accordance with relevant laws and regulations.
- Summary: On November 28, 2017, the Shaanxi Provincial Food and Drug Administration published an announcement detailing findings from comprehensive drug quality sampling inspections conducted across the province. These inspections, aimed at strengthening drug supervision and ensuring public medication safety, identified 30 batches of non-compliant drugs. Multiple pharmaceutical manufacturers in Shaanxi Province were implicated, including prominent entities such as Shaanxi Kangjing Pharmaceutical Co., Ltd., Shaanxi Duoyao Traditional Chinese Medicine Pieces Co., Ltd., and Baoji Xiangyuan Traditional Chinese Medicine Pieces Co., Ltd. The non-compliances primarily involved traditional Chinese medicine pieces and a few finished drug products. Key violations included deficiencies in product properties, identification, general inspection parameters, content determination, and extractives, as well as appearance. These issues indicate failures to adhere to the stringent requirements of regulatory frameworks, specifically the Chinese Pharmacopoeia (2010 and 2015 editions) and the Shaanxi Provincial Standards for Traditional Chinese Medicine Pieces (2008 edition), alongside relevant supplementary inspection methods. In response to these findings, local food and drug regulatory departments have initiated necessary control measures for the affected companies and are conducting investigations and enforcement actions in line with pertinent laws and regulations to resolve these quality issues.

Company: https://www.globalkeysolutions.net/companies/shanxi-kangyi-hengtai-pharmaceutical-co-ltd/130c40dd-ee6c-4b0e-a08d-0d6ff558965b/